Fully Automatic Platelet Aggregometer
- Device class
- Class II
- Model specifications
- LEPUFR2000
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20252220005
- Approval date
- January 02, 2025
- Expiry date
- January 01, 2030
- Name
- Beijing Lepu Medical Technology Co., Ltd.北京乐普诊断科技股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 37, Chaoqian Road, Science and Technology Park, Changping District, Beijing北京市昌平区科技园区超前路37号
- Production address
- 烟台开发区南京大街10号1#厂房1层1101、2层-5层,2#厂房
与北京乐普诊断科技股份有限公司生产的试剂配套使用,适用于血小板聚集率的检测。
全自动血小板聚集仪由检测模块、液路模块、显示触摸模块、电气控制模块、样品杯和样品杯架、和随机软件(发布版本号:1)组成。
10 years
10年
- Remark
- 受托生产企业:烟台艾德康生物科技有限公司;统一社会信用代码:91370600791536775R
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Fully Automatic Platelet Aggregometer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20252220005 and owned by Beijing Lepu Medical Technology Co., Ltd.. The device was approved on January 02, 2025.
This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.